BaclofenAPO-BACLOFEN
Treatment of severe chronic spasticity of cerebral origin, due to multiple sclerosis, due to spinal cord injury, or due to spinal cord disease, in patients who have failed to respond to oral antispastic agents or experienced unacceptable side effects.
Decision on record
- Meeting Jul 2017 Recommended Severe chronic spasticity
Access path
- TGA registered · APO-BACLOFEN
TGA label narrower than the PBS population
- Jul 2017Recommended · restricted
- PBS listing · Restricted
From the public summary
6.1 The PBAC recommended the Section 100 HSD Public Hospital Authority Required (STREAMLINED) listing and a Section 100 HSD Private Hospital Authority Required listing of a new strength of baclofen (40 mg in 20 mL ampoule), with the same indication as the currently listed 10 mg in 5 mL ampoules (the treatment of severe chronic spasticity), at an equivalent price per milligram as the current listing.PSD · Jul 2017
6.2 The submission requested a maximum quantity of two ampoules, totalling 80 mg in 40 mL with each prescription. The Secretariat noted that this is less than the existing listing of baclofen 10 mg/5mL that allows for a maximum quantity of 100 mg. The PBAC noted that the requested maximum quantity is consistent with the intrathecal pump volume used for delivering baclofen, and therefore considered the request was clinically appropriate.PSD · Jul 2017
Cost-effectiveness
Not modelled — this was a minor submission for a new strength formulation with equivalent pricing to the existing baclofen 10 mg/5 mL listing; no economic evaluation was conducted.
Decision context
PopulationPatients with severe chronic spasticity of cerebral origin (due to multiple sclerosis, spinal cord injury, or spinal cord disease) who have failed to respond to treatment with oral antispastic agents or experienced unacceptable side effects.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2017 | Recommended · restricted | — | — | Cost-minimisation |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to cerebral origin spasticity, excluding spinal origin cases covered by the TGA label.